Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Herpes tests: FDA is amending a 2007 regulation that downclassified herpes simplex virus (HSV) serological assays to Class II to remove any reference to HSV assays other than type 1 and type 2 tests. In 1983, FDA classified the pre-amendment devices as Class III, then downclassified type 1 and type 2 tests in 2007 (1"The Gray Sheet" Jan. 16, 2006). Other HSV serological tests remained Class III, but because there are no other types of HSV tests on the market, FDA issued the Aug. 25 rule to prevent confusion. HSV assays were one of 27 types of pre-amendment devices that FDA had yet to downclassify or require PMAs for (2"The Gray Sheet" April 13, 2009). HSV test makers include Quest Diagnostics and Bio-Rad